Principal, Clinical Data Standards

Position Summary: The Clinical Data Standards Architect - Data Collection and Delivery takes a leadership role in the implementation of standard content in -, and related maintenance of the data collection tools and in the definition and maintenance of standard metadata supporting the data flow from data collection to data delivery. The Clinical Data Standards Architect - Data Collection and Delivery is responsible for implementing efficient standards that cover all data capture tools and mechanisms and for the scientific and operational correctness of the collection and metadata standards in support of the R&D portfolio of drug development programs. The Clinical Data Standards Architect - Data Collection and Delivery takes a leadership role in configuring standards to the specific needs and requirements of a Therapeutic Area, compound our Disease Area, generating the expected efficiencies through optimal adoption and reuse of standards. The Clinical Data Standards Architect - Data Collection and Delivery also supports the functions adopting the standards in the clinical trials, in close collaboration with the clinical data collection team. The Clinical Data Standards Architect - Data Collection and Delivery develops deep expertise in industry standards related to data collection and delivery such as Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM), Controlled Terminologies (CT) and Therapeutic Area User Guides (TAUG). The Clinical Data Standards Architect - Data Collection and Delivery provides the leadership in managing contractor or flex staff responsible for the deliverables described above such as the definition and maintenance of the data collection tools and the metadata. Principal Responsibilities: The Clinical Data Standards Architect - Data Collection and Delivery is responsible for the implementation of standard content in data collections tools regardless of the mechanism of collection. Examples of standard content are: Standard Case Report Form Mockups Standard Questionnaires, Rating Scales and Clinical Outcome Assessments Standard Validation Rule Specifications Standard Integrations (e.g. with IWRS) 2. To that end, the Clinical Data Standards Architect - Data Collection and Delivery works closely together with the clinical data collection standards team that facilitates the content definition of these standard data collection tools. 3. The Clinical Data Standards Architect - Data Collection and Delivery is responsible for the implementation of standard content in the collection tools compliant to the industry standards and health authority regulations, meeting best computer system validation practices where applicable. The Clinical Data Standards Architect - Data Collection and Delivery is responsible for the correct testing and QC of the collection tools and therefore collaborates with the respective functions in Integrated Data Analysis and Reporting (IDAR). 4. The Clinical Data Standards Architect - Data Collection and Delivery is responsible over guaranteeing the correctness of the annotated case report form meeting submission, scientific and operational requirements and guidelines. 5. The Clinical Data Standards Architect - Data Collection and Delivery is responsible for the definition and maintenance of standard clinical data collection -, data review - and data delivery metadata for use in clinical trials. The Clinical Data Standards Architect - Data Collection and Delivery is also responsible for the mapping -, and derivation metadata used for automating the data flow from data collection tool (e.g. eCRF) to the Data Review Model (DRM) and from DRM to Study Data Tabulation Datasets (SDTM). 6. The Clinical Data Standards Architect - Data Collection and Delivery consults with the Clinical Data Collection Standards team for scientific correctness of the metadata, with the Clinical Data Analysis Standards team for guaranteeing the delivery metadata meet the analysis requirements and with the Standards Regulatory Intelligence team for the compliance of the metadata with industry regulations. 7. The Clinical Data Standards Architect - Data Collection and Delivery is responsible for overseeing the correct implementation of the metadata supporting the Standard Data Transfer Agreements (DTA) with third party vendors. To that end, the Clinical Data Standards Architect - Data Collection and Delivery works closely together with the clinical data collection standards team that is responsible for developing and maintaining the DTAs and with the representatives from the thirdparty vendors for the correct implementation of the metadata. 8. The Clinical Data Standards Architect - Data Collection and Delivery is responsible for documenting, implementing and maintaining scientifically and operationally correct traceability between domain and variable metadata across the different metadata models, regardless of the mechanism of collection. The Clinical Data Standards Architect - Data Collection and Delivery is also responsible for setting up the standard metadata compliant to the industry standards and health authority regulations. 9. The Clinical Data Standards Architect - Data Collection and Delivery oversees the maintenance of the data collection and metadata standards at a master level to meet additional scientific or operational requirement supporting the R&D portfolio. To that end the Clinical Data Standards Architect - Data Collection and Delivery will guarantee formal change management control and versioning of the standards is applied and adhered to and the Clinical Data Standards Architect - Data Collection and Delivery governs formally all the changes to standards and manages multiple versions in line with adoption needs of the clinical trials and drug development programs. 10. The Clinical Data Standards Architect - Data Collection and Delivery is responsible for the preconfiguration of the standards in line with the specifications of the data lifecycle plan, while maintaining the traceability and lineage of the data. The Clinical Data Standards Architect - Data Collection and Delivery is responsible for documenting and managing correctly the lineage between master standards and the many pre-configured standards. 11. The Clinical Data Standards Architect - Data Collection and Delivery guarantees adequate documentation such usage and implementation guidelines of the standards in studies, over tailored and effective training and over targeted communication to the user community. 12. The Clinical Data Standards Architect - Data Collection and Delivery will provide the necessary support to the clinical data standards team and the clinical analysis team who facilitate the consistent adoption of standards in the studies (internally or outsourced to a CRO). To that end, the Clinical Data Standards Architect - Data Collection and Delivery will use adoption and conformance metrics to identify potential improvements in the adoption of standards in the studies to maximize the value of standards. 13. The Clinical Data Standards Architect - Data Collection and Delivery participates in process, system, and tool improvement initiatives across the clinical development standards and Integrated Data Analytics and Reporting (IDAR). 14. The Clinical Data Standards Architect - Data Collection and Delivery is responsible in acquiring and maintaining deep expertise in the various data collection tools applied in the clinical trials such as Rave eDC and DTAs, Clinical Data Tools such as LSAF and Pinnacle 21, and in CDISC standards such as SDTM, CDASH, Controlled terminology and define.xml. The Clinical Data Standards Architect - Data Collection and Delivery is encouraged to become member of industry initiatives related to the development of industry standards. Principal Relationships: Contacts in the organization: Clinical Data Collection Standards Clinical Data Analysis Standards Standards Regulatory Intelligence IDAR niche experts (trial set up and integration) IDAR technical and disease experts IDAR global data managers Therapeutic Area Scientists EBIS TPO (e.g. integrations, ePRO) Contacts outside of the organization: CDISC working groups Standard Data Collection Tools build service providers Contract research organization (CRO) adopting the standard data collection tools in clinical studies Qualifications Education and Experience Requirements: Contacts in the organization: Clinical Data Collection Standards Clinical Data Analysis Standards Standards Regulatory Intelligence IDAR niche experts (trial set up and integration) IDAR technical and disease experts IDAR global data managers Therapeutic Area Scientists EBIS TPO (e.g. integrations, ePRO) Contacts outside of the organization: CDISC working groups Standard Data Collection Tools build service providers Contract research organization (CRO) adopting the standard data collection tools in clinical studies Primary Location Belgium-Antwerp-Beerse- Other Locations Europe/Middle East/Africa, North America Organization Janssen Cilag Ltd. (7360) Job Function R&D Requisition ID 2206069590W